Advice Pa t i e nt ca re a n d s a fe t y Prescribing Prescribing and medicines management

Prescribing and medicines management

A general introduction to prescribing and dispensing medicines to dental patients.

This advice provides a general introduction to prescribing and dispensing medicines to dental patients, including:

Requirements for prescribing or dispensing to private and NHS patients

Your responsibilities under the Consumer Protection Act and how you can avoid liability for a defective medicine
Labelling requirements for any medicines you provide
Information that must be included on any prescription for patients and the rules for describing quantities
Special circumstances that require modifications to normal prescribing.

You must only prescribe medicines that are necessary and must always consider the benefits to the patient against the risks associated with the medicine. As a dentist, you
can sell or supply medicines to your patients but, for NHS patients, you must abide by restrictions imposed by NHS regulations.

If you supply medicines to your patients, you must follow good prescribing practice and maintain auditable supply and dispensing records to ensure the patient retains a
clear route to the manufacturer, importer, or supplier to avoid you being liable for damage resulting from a defective medicine.

You can provide your patients with controlled drugs necessary for their dental treatment and must follow the requirements for prescriptions, storage and disposal and have
up-to-date standard operating procedures.

Classification of medicines
The Human Medicines Regulations 2012 consolidate previous UK legislation concerning medicinal products for human use. A medicinal product is a substance or
combination of substances that may be administered with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions.
Dental materials are not covered by the definition.

The classification of medicines depends, in part, on the need for a health professional to diagnose and treat a condition. There are three categories: prescription-only,
pharmacy and general sales list medicines.

Prescription-only medicines (POMs) must be prescribed by an authorised health professional and dispensed from a pharmacy where the medicine is prepared under
the supervision of a pharmacist
Pharmacy (P) medicines do not require a prescription and may be sold or supplied only in a registered pharmacy by or under the supervision of a pharmacist. The
package gives information on dosage. For some medicines (for example, Paracetamol), the size of the pack will reclassify it as a POM
General sale list (GSL) medicines can be sold in general retail outlets without the supervision of a pharmacist. They are often referred to as ‘over the counter’
medicines. GSL medicines must be sold in manufacturer’s packs.

The Regulations include an exemption for dentists, allowing you to sell or supply POMs, P and GSL medicines to your patients, subject to the restrictions imposed by NHS
regulations.

Providing medicines to your patients

The exemption allowing dentists to sell or supply medicines to their patients and the restrictions imposed by NHS regulations have implications for how you provide
medicines to your private and NHS patients. The British National Formulary (BNF) provides useful guidance on the medicines listed, including indications and dose,
interactions, side-effects, pregnancy, and patient advice. It also provides general guidance on prescribing in dental practice , which includes medical emergencies
and medical problems in dental practice.

Private patients
Where a private patient requires medicines as part of their treatment, you should provide a private prescription or supply the required medicines (without or without a
charge). You must not provide a private patient with an NHS prescription. We provide members with a template for private prescriptions . If you supply medicines, you
must comply with the requirements for container safety, labelling, patient information and product liability. Additional requirements apply to controlled drugs. The
Regulations do not limit the medicines that you can administer or prescribe to a patient under your care, but you should prescribe only within your areas of experience and
competence and to meet the identified needs of your patients.

You do not need to liaise with a patient’s GP when prescribing in relation to dental treatment, but there may be occasions when it would be appropriate to do so.

NHS patients
You must use an NHS prescription form (FP10D in England and Wales, GP14 in Scotland and HS47 in Northern Ireland) to prescribe medicines for NHS patients. You can
only prescribe medicines from the List of Dental Preparations in the Dental Practitioners’ Formulary. Brand names are included for easy identification, but you
should use the non-proprietary (generic) name when prescribing a medicine.

Provide NHS patients, at no extra charge, with the medicines they require for immediate use and provide an NHS prescription for medicines needed after the appointment.
Prescriptions must be dispensed by a registered pharmacist; you cannot sell medicines to patients receiving NHS care. You should only prescribe the appropriate amounts of
drugs necessary for the proper treatment of the patient and avoid excessive prescribing.

Some P and GSL medicines may be purchased for less than the prescription charge; encourage non-exempt patients check the price before presenting the prescription.

Supplying and dispensing medicines

Under the Consumer Protection Act 1987, an individual who suffers damage because of a defective product must demonstrate that the product was defective and that the
damage was the result of the defective product. Liability for damage generally falls upon the producer or importer of the finished product but, to give the claimant a clear
route of action, strict liability will attach to any supplier of a product who cannot identify a supplier or producer further up the supply chain.

If you dispense medicines to your patients, you must keep records of supplies for 11 years to ensure that the patient retains a clear route to the manufacturer, importer or
supplier to avoid you being liable for damage resulting from a defective medicine.

You can also be liable for damage, if you prescribe a medicine in a higher than specified dose or for a condition not listed. Always check the BNF for up-to-date
information.

To minimise the risk of liability, you should:

Keep accurate records of the source of all medicines held by the practice, including the dates they were received, batch number and expiry dates
Keep accurate records of the supply and administration of all medicines to patients. When administering local anaesthetic (LA), make a note in the patient’s records
of the formulation of LA given, the dose, the type of injection given (infiltration, intra-ligamental or block) and the site of injection if not obvious from the treatment
provided
Retain all records of supply for 11 years
Avoid breaking manufacturers’ original packs, where possible
Dilute or prepare medicines only in accordance with the manufacturers’ instructions
Ensure that the manufacturer’s name or any cautionary advice is not removed from the packaging or obscured by the label
Store all medicines according to the manufacturers’ recommendations
Make sure you are adequately insured/indemnified against professional negligence and product liability claims.

Patient packs and containers

Many medicines are available in the manufacturer’s original packs complete with patient information leaflets; the BNF shows the number of dose units available in the
packs. Where patient packs need to be split or medicines are provided in bulk dispensing packs, manufacturers will provide additional supplies of patient information
leaflets on request.

Bulk supplies of medicines should be dispensed in containers that are opaque or dark tinted and re-closable. Child-resistant containers should be used, unless they are
inappropriate for the patient – for example, if the patient has limited manual dexterity. You will, however, be liable for any injury or harm that arises from not using child-
resistant containers.

You must comply with labelling requirements for any medicines that you supply and ensure that containers show:

Patient’s name
Name and address of the supplying dentist
Dispensing date
Name of medicine and expiry date
Directions for use and precautions
The words ‘keep out of the reach of children’
The phrase “for external use only” if the medicine is a liquid preparation of gel and is for external use only and is not on a general sales list.

Record keeping and prescriptions

Record on the patients’ notes all details of the prescription given (including the name of the medicine prescribed, the dosage and the duration of treatment) and the
justification for it. If dispensing medicines directly to patients in the practice on a private basis, you should produce a written private prescription on practice headed paper
and include the patient identifiers and date of issue. The prescription should be kept with the patient records.

Storage of medicines
You should store medicines according to the manufacturers’ recommendations. Medicines may undergo chemical or physical deteriorations, especially when stored in
extremes of temperature, damp or in direct sunlight. Change usually takes the form of reduced therapeutic effectiveness and can, if significant, have serious implications.
For example, incorrect storage of adrenaline may make it inactive, which could have serious implications in the treatment of anaphylactic shock.

Stocks of medicines should be kept to the minimum required for routine needs and foreseeable emergencies. Accurate record keeping and stock checks will identify out-of-
date medicines for disposal.

Non-emergency medicines should be kept in a locked cupboard.

Patient Group Directions

Patient group directions (PGDs) are written instructions to help you supply or administer medicines to patients, usually in planned circumstances and where there is an
advantage for the patient without compromising their safety.

A PGD should be put together by a multi-disciplinary group, including a dentist, a pharmacist, a representative of your NHS body (for NHS patients) or the dental business
(for private patients) and the practice manager. A PGD can last for up to three years.

A PGD must include

The name of the business who owns the direction

The start and end date of the PGD
A description of the medicine(s)
The class of the health professional who can supply or administer the medicine
A signature of a dentist and a pharmacist
Authorisation by an appropriate organisation
The clinical condition or situation to which the direction applies
A description of patients excluded from treatment under the direction
A description of when you should get more advice from a dentist and arrangements for referral
Details of appropriate dosage, maximum total dosage, quantity, pharmaceutical form and strength, route and frequency of administration, and minimum or
maximum period to administer the medicine
Relevant warnings, including potential adverse reactions
Details of any necessary follow-up actions
A statement of the records to be kept for audit purposes.

A PDG can be used to supply POMs, P and GSL medicines. In dentistry, a PDG is usually used to allow hygienists and therapists to administer local anaesthetics and to sell or
supply fluoride supplements and toothpastes with high fluoride content of 2800 and 5000 parts per million (ppm). If a PGD is to be used for systemic antibiotics, a local
microbiologist should be involved to ensure strategies to combat increasing resistance are not jeopardised.

Good prescribing practice

You must only prescribe medicines that are necessary; always consider the benefits of administering the medicine in relation to the risk involved. This is particularly
important during pregnancy, when the risk to both mother and foetus must be considered.

You must discuss treatment options with the patient and ensure that they are content to take the medicine as prescribed. You should help the patient to distinguish the
adverse effects of prescribed drugs from the effects of the dental condition being treated and let them know if the beneficial effects of the medicine are likely to be
delayed.

Factors that contribute to poor compliance with prescribed medicines include

The prescription was not collected or not dispensed

The purpose of medicine was not clear
Perceived lack of efficacy
Real or perceived adverse effects
The patient’s perception of the risk and severity of side-effects may differ from the prescriber’s
Unclear instructions for administration
Physical difficulty in taking medicines (for example, swallowing the medicine, handling small tablets, or opening medicine containers)
Unattractive formulation (for example, unpleasant taste)
Complicated regimen.

You should understand the patient’s desired health outcomes and agree a strategy for achieving them. Be sensitive to religious, cultural, and personal beliefs that might
affect a patient’s acceptance of medicines – for example, prescribing a mouthwash containing alcohol may not be compatible with a patient’s religion or culture.

Check and update a patient’s medical history at the start of each new course of treatment and review it at each subsequent visit. Knowing the medicines that a patient is
taking, allows you to check for drug interactions before prescribing or supplying medicines in connection with their dental treatment. Ask about herbal and alternative /
complementary medicines as some may interact with conventional therapy (St John’s Wort, for example).
Make sure that the patient understands how to dispose of any unwanted medicines, for example, by returning them to the community pharmacist and not via the
sewerage system or domestic waste system or shared with others.

The doses stated in the BNF represent, unless otherwise stated, the usual range of doses that are generally suitable for adults. Medicines that are suitable for children
include the recommended range of doses. You should prescribe the minimum amount required to meet the patient’s need.

Prescription writing
Prescriptions should be written legibly in permanent ink, be dated and state the name and address of the patient. The age and date of birth of the patient should be stated;
where the patient is under 12 years, this is mandatory. Including the weight of the child enables the prescribed dose to be checked. The prescriber should state their address
and profession and sign the prescription in ink.

State the dose, dose frequency and number of days of treatment required. Where the preparation is to be taken ‘as required’, you should state the dose and
frequency or the quantity to be supplied
Avoid using unnecessary decimal points
- quantities of 1 gram or more should be written as 1g etc.
- quantities of less than 1 gram should be written in milligrams – 500mg, not 0.5g
- quantities of less than 1mg should be written in micrograms – 100 micrograms and not 0.1mg
When a decimal point is unavoidable, use a zero before the decimal point where there is no other figure – 0.5ml, not .5ml
Use approved titles for names of medicines and preparations, not abbreviations.

Blank NHS prescription forms should be stored securely to avoid their theft and misuse:

Keep the prescription pad in a locked drawer to ensure that it is not visible
Stamp each prescription as you need it; avoid stamping multiple prescriptions for future use
Draw a diagonal line across the blank part of the form under the prescription to avoid additions being made after issue to the patient
Write the quantity in words and figures (mandatory when prescribing controlled drugs)
Amendments to the prescription should be clear and unambiguous; initial any amendments you make
If the prescription is to be collected, you should keep it in sealed envelope and in a safe place.

Computer-generated prescriptions
You should use dedicated software when generating prescriptions electronically. The software should include a dictionary of the drugs listed in the BNF and information on
the usual dosage, formulations and pack sizes to produce standard predetermined prescriptions for common preparations. The guidance for generating an electronic
prescription is the same as for hand- written prescriptions.

Remote prescribing
A faxed, emailed or telephoned prescription does not meet the valid-prescription requirements. A fax can confirm that at the time of receipt, a valid prescription was in
existence. A pharmacist is not obliged to dispense against a faxed prescription, but if they do, they must be sure of the integrity of the original prescription and that they
will receive it within a short time. Remote prescribing should only be used in exceptional circumstances and not in relation to non-surgical cosmetic procedures.

Emergency supplies of POMs

In an emergency, a pharmacist can dispense medicines without a prescription at the request of a dentist, if

The pharmacist is satisfied that you cannot immediately provide a prescription

You undertake to provide a prescription within 72 hours
The medicine is supplied as you have requested
The medicine is not a controlled drug specified in Schedules 1, 2, or 3 to the Misuse of Drugs Regulations 2001
The pharmacist makes an entry in their prescription book.

Self-prescribing and prescribing for family

You must only prescribe where you can form an objective view of your patient’s health and clinical needs. Prescribing medicines for yourself or those who are close to you,
may make it difficult for you to remain objective. You risk overlooking serious problems, encouraging, or tolerating addiction, or interfering with care or treatment provided
by other healthcare professionals. You should, therefore, avoid prescribing drugs for yourself or for anyone with whom you have a close personal or emotional relationship.

Prescribing antimicrobials for oral and dental infections

Antimicrobials are prescribed to manage oral and dental infections. The benefits are limited by problems associated with their use, including the development of resistant
strains of microbes. Antimicrobial resistance is now a major public health problem with serious implications for the future treatment of infectious disease.

Only prescribe antimicrobials when there is a clear clinical need and not as an alternative to definitive clinical treatment. Many patients may not understand the problem of
antimicrobial resistance resulting from overuse and pressure you to prescribe antibiotics when they are not indicated. Guidance on prescribing antimicrobials in
general dental practice is available from the FGDP.

The antimicrobial stewardship toolkit will help you to follow dental prescribing guidelines and help your patients understand when antibiotics are appropriate.

Prophylaxis against infective endocarditis

Antibiotic prophylaxis against infective endocarditis is not recommended routinely for people undergoing dental procedures. You should offer the most appropriate
treatment options, in consultation with the patient. Your clinical judgement should take account of the NICE recommendations and the values and preferences of
patients.

Adverse reactions
Any medicine may produce unwanted or unexpected adverse reactions. Rapid detection and recording of adverse reactions allows unrecognised hazards to be identified
promptly and appropriate regulatory action to be taken to ensure that medicines are used safely. You should report suspected adverse reactions to the Medicines and
Healthcare products Regulatory Agency (MHRA) using the Yellow Card Scheme .

Prescribing in special circumstances

To prescribe medicines safely, you must have a comprehensive, up-to-date medical history for your patient, which you should check with the patient before prescribing them
any medicines. The BNF contains useful guidance on situations that require modifications to normal prescribing: pregnancy , breast-feeding , the elderly ,
children , and hepatic and renal impairment. Summaries of the guidance are included here but you are advised to refer to the full BNF guidance.

Pregnancy
Medicines taken during pregnancy can be harmful to the foetus. You should only prescribe them if the expected benefit to the mother is thought to be greater than the risk
to the foetus; all drugs should be avoided during the first trimester. Medicines that have been extensively used in pregnancy and appear to be usually safe should be
prescribed in preference to new or untried medicines; and the smallest effective dose should be used. Few medicines have been shown conclusively to interfere with the
development of the foetus, but no medicine is safe beyond all doubt in early pregnancy. See also the UK Teratology Information Service .

Breast-feeding
Some medicines taken by the mother whilst breast-feeding can be transferred to the breast milk and may affect the infant, although there is little information available. The
amount of medicines transferred in breast milk is rarely enough to produce a discernible effect on the infant but there is a theoretic possibility that a small amount present
in breast milk can induce a hypersensitivity reaction.

For many medicines, insufficient evidence is available to provide guidance and you should administer only essential medicines to a breast-feeding mother.

The elderly
Old people, especially the very old, require special care and consideration. Elderly people often receive multiple medicines for their multiple diseases, which increases the risk
of drug interactions and adverse reactions – both of which may affect compliance.

You should always consider whether a medicine is indicated at all. Prescribing from a limited range allows you to be familiar with their effects in elderly people. Dosage is
likely to be substantially lower than for younger patients and it is common to start with about 50% of the adult dose. Elderly patients benefit from simple treatment
regimens, and you should write full instructions on every prescription so that the container can be properly labelled. Child-resistant containers may be unsuitable, but you
will, however, be liable for any injury or harm that arises from not using child-resistant containers

Frail elderly patients may have difficulty swallowing tablets; if left in the mouth, ulceration may develop. You should encourage them to take their tablets or capsules with
enough fluid and when sitting or standing upright (to avoid oesophageal ulceration). A liquid alternative, if available, may be helpful.

Children
Detailed advice on medicines used for children is available in the BNF for Children .

Children, and particularly neonates, differ from adults in their response to medicines. Children’s doses in the BNF are stated in the individual medicine entries and are
generally based on body weight or specific age ranges. Young children may require a higher dose per kilogram than adults because of their higher metabolic rate. In
overweight children, however, you should calculate the dose from an ideal weight to avoid prescribing a higher than necessary dose. You must also include the age of
children under 12 years and, preferably, for all children.

Many children can swallow tablets or capsules and may prefer a solid dose form; involving the child and parents in choosing the formulation is helpful.

Controlled drugs
The Misuse of Drugs Act 1971 prohibits certain activities relating to the manufacture, supply and possession of controlled drugs. The drugs are graded according to their
harmfulness when misused: Class A, Class B and Class C.

The Misuse of Drugs Regulations 2001 define who can supply and possess controlled drugs while acting in a professional capacity and the conditions that must be met.
Controlled drugs are divided into five schedules, each specifying the requirements governing import, export, production, supply, possession, prescribing and record keeping.

You can prescribe or administer controlled drugs to your patients but only in relation to their dental treatment. Pharmacists are likely to challenge dental prescriptions for
controlled drugs in Schedule 2 or Schedule 3 for which there is no recognised dental use. You can only prescribe the following controlled drugs using an NHS prescription
form:

Schedule 3: temazepam tablets, temazepam oral solution

 Schedule 4: diazepam tablets, diazepam 2mg/5ml oral solution
Schedule 5: dihydrocodeine 30mg tablets.

Midazolam (a Schedule 3 drug) is also used in dentistry but is not for use by patients outside the dental surgery.

Prescription requirements
A prescription for controlled drugs must be indelible, signed by the prescriber, dated, and specify the prescriber’s unique code and address. It must also state:

The name and address of the patient

The name of the preparation and the dosage form (for example, tablets) and, where appropriate, the strength
For liquids, the total volume in millilitres (in both words and figures); for dosage units, the number (in both words and figures) of dosage units to be supplied
The dose
‘CD’ after the order for the controlled drug
The words ‘for dental treatment only’.

You must use a dedicated controlled drugs prescription form for

NHS patients requiring any controlled drug

Private patients requiring a controlled drug in Schedule 2 or Schedule 3. Private prescriptions for Schedule 4 and Schedule 5 drugs should follow general prescription-
writing requirements.

NHS PATIENTS PRIVATE PATIENTS NHS AND PRIVATE FORMS OBTAINED FROM

ENGLAND FP10D FP10PCD NHS England Area Team

NORTHERN IRELAND HS21D PCD1 Central Services Agency

SCOTLAND GP14 PPCD Health Board

WALES WP10D WP10PCD Local Health Board

Prescriptions for schedule 2, 3 and 4 controlled drugs are valid for 28 days and should be limited to the quantity necessary for up to 30 days. Where there is a clinical need
to prescribe for more than 30 days, you must record the reason in the patient records.

Prescription requirements
Midazolam (Schedule 3) is recommended for the emergency management of status epilepticus. It (and other controlled drugs) can be obtained using the relevant
requisition form: FP10CDF (England), GP10A (NHS, Scotland), CDRF (private, Scotland) and WP10CDF (Wales).

The completed form can be submitted to a dental wholesaler that supplies pharmaceutical preparations, including controlled drugs. The official requisition form must be
provided to the wholesaler. Or you might obtain supplies from a community pharmacist who is registered to issue controlled drugs via a requisition.

You will need to provide the following information on the requisition form:

The name, form, strength and quantity of the drug

The purpose for which the drug is required
Your details, including your professional qualification
Your unique code.

Including your GDC number alongside your professional qualification will allow the supplier to check that the requisition is valid. You must sign a controlled drug requisition.

Safe custody
All controlled drugs in Schedule 2 and some Schedule 3 drugs (including temazepam) are subject to safe custody requirements and must be kept in a locked controlled drug
cabinet that complies with the Misuse of Drugs (Safe Custody) Regulations. Controlled drugs in other schedules (and midazolam) do not require storage in a locked
controlled drug cabinet.

If you hold supplies of Schedule 2 drugs (for example, morphine), you must maintain a register of controlled drugs.

It is a legal requirement that you must keep invoices for all controlled drugs for a minimum of two years. However, it is recommended that if you dispense medicines to your
patients, you should keep the invoices for 11 years to ensure that the patient retains a clear route to the manufacturer, importer or supplier to avoid you being liable for
damage resulting from a defective medicine.”

Disposal
You must destroy and dispose of unwanted or unusable controlled drugs safely. Schedule 2 drugs require witnessed destruction by an individual authorised under the
Misuse of Drugs Regulations. Your local Accountable Officer (or similar) can provide advice.
Before disposal, Schedule 2, 3 and 4 (part 1) drugs should be unrecognisable and must be denatured, dissipated, or rendered irretrievable. Part-used or out-of-date
ampoules (midazolam, for example) can be disposed of using a controlled drug denaturing kit (available from your contracted waste management company) or by
allowing the ampoule contents to be absorbed by cat litter (or similar product). The empty ampoule and absorbent material should be disposed of in the sharps bin and
labelled ‘contains mixed pharmaceutical waste and sharps – for incineration’.

You must not put part-used ampoules (of midazolam, for example) directly into pharmaceutical waste or sharps containers.

Standard operating procedures

Healthcare organisations should have standard operating procedures (SOPs) for the use and management of controlled drugs, which cover:

Who has access to the controlled drugs

Where the drugs are stored
Security in relation to storage and transportation
Monitoring and recording stock
Checking expiry dates and disposal/destruction of expired drugs
Reporting loss or suspected theft – normally to the Accountable Officer
Controlled drugs records, including requisitions, invoices, private and NHS prescriptions, transport and delivery notes, and record keeping (including drug registers,
critical incidents, errors, and near misses).

Your local Accountable Officer (or similar) is responsible for ensuring SOPs are adequate and up to date.

All team members should have the relevant knowledge and skills to managing controlled drugs safely and should be aware of the procedures for whistleblowing if they have
a concern, involving controlled drugs, about the performance or practice of a colleague.

Members with BDA Indemnity are advised to discuss the matter with a dento-legal advisor.

SPEAK TO OUR EXPERTS

Further information
Faculty of General Dental Practice (FGDP) – Adult antimicrobial prescribing in primary dental care for GDPs
Scottish Dental Clinical Effectiveness Programme (SDCEP) – Drug prescribing for dentistry
NICE guidance – Antimicrobial stewardship: systems and processes for effective antimicrobial medicine use
NHS Choices – Dental abscesses and treatment
GOV.UK – 5-year antimicrobial resistance strategy

SEE 'MEDICAL EMERGENCIES' FOR MORE

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